(216 days)
The MAC External Fixation System is a unilateral external fixation device intended for use in children and adults in the treatment of bone conditions including leg lengthening, osteotomies, arthrodesis, fracture fixation, and other bone conditions amenable to treatment by use of the external fixation modality. The addition of the MAC Male Adapter does not change the indications for use for the MAC External Fixation System.
The purpose of this submission is to add a Male Adapter Assembly to the previously cleared MAC External Fixation System. The subject MAC Male Adapter Assembly is intended to attach to the existing MAC Module), and allows the MAC to connect to other external fixation components, including: Construx Female Telescoping Arm, Carbon T-clamp, the DFS Angular Hinge and the Carbon Ankle component. These connections allow the surgeon to treat a variety of bone conditions amenable to treatment by use of the external fixation modality.
The provided text describes a 510(k) summary for the "MAC External Fixation System," specifically regarding the addition of a "Male Adapter Assembly." The acceptance criteria and supporting evidence are related to the mechanical performance of this new component.
Here's a breakdown of the requested information based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Static construct testing met pre-established acceptance criteria established by predicate devices. | The assembled constructs (MAC Male Adapter + aluminum components, and carbon components) met the pre-established acceptance criteria established by the predicate devices. |
| Fatigue construct testing to one million cycles met pre-established acceptance criteria established by predicate devices. | The assembled constructs (MAC Male Adapter + aluminum components, and carbon components) met the pre-established acceptance criteria established by the predicate devices. |
Study Details
The study described is a mechanical testing study to demonstrate substantial equivalence, not a clinical study involving human patients or complex AI algorithms. Therefore, many of the requested fields are not applicable (N/A) in this context.
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of constructs tested, but it refers to "assemblies" of the MAC Male Adapter with aluminum and carbon components.
- Data Provenance: N/A (Mechanical testing, not human data). The testing was conducted internally or by a testing facility as part of the regulatory submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A. Ground truth here refers to engineering specifications and performance benchmarks derived from predicate devices, not expert human interpretation.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: N/A. Mechanical testing results are objective measurements against defined criteria, not subjective interpretations requiring adjudication.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: N/A. This is a mechanical device, not an AI-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A. This is a hardware device; there is no algorithm involved.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for performance was established by "pre-established acceptance criteria established by the predicate devices." This implies engineering specifications and performance benchmarks derived from similar, already approved external fixation systems.
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The sample size for the training set: N/A. This refers to mechanical testing, not a machine learning model.
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How the ground truth for the training set was established: N/A. No training set is applicable here. The "ground truth" for the mechanical tests was based on performance criteria derived from predicate devices.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.